Super Sheath R/ORecalls & reported problems across all models
Togo Medikit CO.,Ltd. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 82
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 9 models of Super Sheath R/O by Togo Medikit CO.,Ltd. in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2018 and Mar 14, 2025 — classified as 3 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (64 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Super Sheath R/O problems
Device problems
- Device Contamination with Chemical or Other Material64
- Device Contaminated During Manufacture or Shipping9
- Difficult to Remove4
- Break2
- Detachment of Device or Device Component2
- Difficult to Advance2
- Difficult to Insert2
- Use of Device Problem2
Patient problems
- No Consequences Or Impact To Patient40
- No Patient Involvement34
- No Clinical Signs, Symptoms or Conditions5
- Extravasation2
- Pain2
- Foreign Body In Patient1
- No Code Available1
Super Sheath R/O models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Super Sheath R/O (15-962B) BT60Z11PPWX38INTRODUCER, CATHETER49 reports
- Super Sheath R/O (15-963B) BT70Z11PPWX38INTRODUCER, CATHETER14 reports
- Super Sheath R/O (15-964B) BT80Z11PPWX38INTRODUCER, CATHETER8 reports
- Super Sheath R/O (15-961B) BT50Z11PPWX38INTRODUCER, CATHETER4 reports
- Super Sheath R/O (15-960B) BT40Z11PPWX35INTRODUCER, CATHETER2 reports
- Super Sheath R/O (15-969B) BT90Z11TPWX38INTRODUCER, CATHETER2 reports
- Super Sheath R/O (15-957B) BT60Z07PPWX38INTRODUCER, CATHETER1 report
- Super Sheath R/O (15-958B) BT70Z07PPWX38INTRODUCER, CATHETER1 report
- Super Sheath R/O (15-965B) BT60Z25PPWX38INTRODUCER, CATHETER1 report
Recent Super Sheath R/O adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 14, 2025Difficult to Insert; Use of Device Problem; Difficult to Insert; Use of Device Problem
IT WAS REPORTED THAT THE SHEATHS WERE DIFFICULT TO ADVANCE THROUGH THE SKIN RESULTING IN PAIN AND PERINEPHRIC URINOMA WAS TREATED MEDICALLY. TWO 9 FR X 11 CM SUPER SHEATH INTRODUCER SHEATHS OF THE SAME LOT WERE USED DURING THIS ANTEGRADE URETERIC STENTING OF THE RIGHT KIDNEY. IT WAS REPORTED THAT THE SHEATHS WERE DIFFICULT TO ADVANCE THROUGH THE SKIN TO THE RIGHT KIDNEY CAUSING A LOT OF PAIN TO THE RIGHT SIDE OF THE BACK ACCESS POINT. THE RADIOLOGIST DILATED UP TO A 10 FR DILATOR (USING DILATORS - 6,7,8,9,10) TO AID DILATION OF THE TRACK FOR THE 9 FR SHEATH PLACEMENT WITH DIFFICULTY. THE STENT WAS SUCCESSFULLY PLACED. AS A RESULT OF THE PAIN, THE PATIENT WAS TREATED IMMEDIATELY POST-PROCEDURE WITH PARACETAMOL, IBUPROFEN AND IV FENTANYL. THE PATIENT HAD PROGRESSIVE WORSENING PAIN, AND A CT SCAN REVEALED AN EXTRAVASATION OF CONTRAST IN KEEPING WITH A PERINEPHRIC URINOMA WHICH MAY HAVE BEEN CONTRIBUTED TO BY THE SHEATH OR THE ASSOCIATED DILATATION REQUIRED TO INSERT IT. THE PATIENT WAS REFERRED TO UROLOGY FOR INPATIENT ADMISSION FOR ONGOING OBSERVATION AND PAIN MANAGEMENT, IV FLUIDS. THE PATIENT HAD SOME URINARY RETENTION RELATED TO THEIR BLADDER OUTFLOW OBSTRUCTION THAT RESULTED IN W
Patient problems: Extravasation; Pain
MAUDE report 21607201 ↗InjuryMar 14, 2025Difficult to Insert; Use of Device Problem; Difficult to Insert; Use of Device Problem
IT WAS REPORTED THAT THE SHEATHS WERE DIFFICULT TO ADVANCE THROUGH THE SKIN RESULTING IN PAIN AND PERINEPHRIC URINOMA WAS TREATED MEDICALLY. TWO 9 FR X 11 CM SUPER SHEATH INTRODUCER SHEATHS OF THE SAME LOT WERE USED DURING THIS ANTEGRADE URETERIC STENTING OF THE RIGHT KIDNEY. IT WAS REPORTED THAT THE SHEATHS WERE DIFFICULT TO ADVANCE THROUGH THE SKIN TO THE RIGHT KIDNEY CAUSING A LOT OF PAIN TO THE RIGHT SIDE OF THE BACK ACCESS POINT. THE RADIOLOGIST DILATED UP TO A 10 FR DILATOR (USING DILATORS - 6,7,8,9,10) TO AID DILATION OF THE TRACK FOR THE 9 FR SHEATH PLACEMENT WITH DIFFICULTY. THE STENT WAS SUCCESSFULLY PLACED. AS A RESULT OF THE PAIN, THE PATIENT WAS TREATED IMMEDIATELY POST-PROCEDURE WITH PARACETAMOL, IBUPROFEN AND IV FENTANYL. THE PATIENT HAD PROGRESSIVE WORSENING PAIN, AND A CT SCAN REVEALED AN EXTRAVASATION OF CONTRAST IN KEEPING WITH A PERINEPHRIC URINOMA WHICH MAY HAVE BEEN CONTRIBUTED TO BY THE SHEATH OR THE ASSOCIATED DILATATION REQUIRED TO INSERT IT. THE PATIENT WAS REFERRED TO UROLOGY FOR INPATIENT ADMISSION FOR ONGOING OBSERVATION AND PAIN MANAGEMENT, IV FLUIDS. THE PATIENT HAD SOME URINARY RETENTION RELATED TO THEIR BLADDER OUTFLOW OBSTRUCTION THAT RESULTED IN W
Patient problems: Extravasation; Pain
MAUDE report 21607191 ↗InjuryFeb 10, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT REMOVAL DIFFICULTY AND DEVICE DETACHMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED ARTERIOVENOUS (AV) FISTULA. A 6 FR X 7 CM N/G SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE IN A DECLOT PROCEDURE. HOWEVER, DURING REMOVAL, THE SHEATH FRACTURED AND DETACHED. A SNARE WAS USED TO RETRIEVE THE DETACHED SHEATH. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21345879 ↗MalfunctionDec 5, 2023Difficult to Remove; Difficult to Advance; Material Integrity Problem; Difficult to Remove; Difficult to Advance; Material Integrity Problem
IT WAS REPORTED THAT THE SHEATH WAS DIFFICULT TO REMOVE. A 6FR INTRODUCER SHEATH WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE TO TREAT AN OCCLUDED VESSEL. DURING INSERTION OF THE SHEATH, THERE WAS DIFFICULTY ADVANCING THE SHEATH. WHEN THE SHEATH WAS REMOVED, THE TIP WAS DEFORMED. IT WAS DIFFICULT TO REMOVE, AND THE TIP CAUGHT ON THE VESSEL WALL. A NEW SHEATH WAS SELECTED FOR USE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18270360 ↗MalfunctionDec 5, 2023Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility
IT WAS REPORTED THAT THE SHEATH WAS DIFFICULT TO REMOVE. A 5FR INTRODUCER SHEATH WAS SELECTED FOR USE IN A TRANS-ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE. VASCULAR ACCESS WAS OBTAINED VIA A PUNCTURE OF THE RIGHT COMMON FEMORAL ARTERY (CFA). THE INTRODUCER SHEATH WAS ADVANCED INTO THE ARTERY OVER A STANDARD 0.035 GUIDEWIRE. A NON-BSC DIAGNOSTIC CATHETER WAS ADVANCED OVER THE GUIDEWIRE AND TORQUED 360 DEGREES. AT THIS POINT IT WAS OBSERVED THAT THE CATHETER COULD NOT BE RETRACTED, AND A GUIDEWIRE COULD NOT PASS THROUGH IT. A 0.018 NON-BSC GUIDEWIRE WAS ATTEMPTED FOR USE, BUT WAS UNSUCCESSFUL. THE CATHETER WAS MANAGED TO BE REMOVED WITH DIFFICULTY, AND A NEW .035 NON-BSC GUIDEWIRE WAS ADVANCED INTO THE AORTA. IT WAS THEN OBSERVED THAT THE CATHETER WAS COMPLETELY TWISTED ON ITSELF. THE SHEATH WAS THEN REMOVED, HOWEVER, IT WAS CRUMPLED AND DIFFICULT TO REMOVE. A NEW 5FR INTRODUCER SHEATH WAS SELECTED FOR USE. THERE WAS DIFFICULTY ADVANCING THE SHEATH INTO THE VESSEL. THE SHEATH WAS OBSERVED TO HAVE COILED UP UNDER THE SKIN WHICH RESULTED IN A HEMATOMA. A NEW 5FR SHEATH WAS SELECTED FOR USE. THE PROCEDURE WAS THEN ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO FURTHER PA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18268060 ↗MalfunctionMay 31, 2023Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 6 FR X 25 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO ACCESS THE RIGHT ILIAC FROM A CONTRALATERAL APPROACH. HOWEVER, IT WAS NOTED THAT THE SHEATH WAS KINKED NEAR THE TIP OVER THE AORTIC BIFURCATION. CONSEQUENTLY, DIFFICULTY ADVANCING AND REMOVING THE SHEATH OCCURRED, AND THE PROCEDURE WAS DISCONTINUED. THE SHEATH WAS REMOVED INTACT FROM THE PATIENT'S BODY AND NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17030159 ↗MalfunctionSep 7, 2021Break; Break
IT WAS REPORTED THAT THE RADIOPLAQUE TIP BROKE OFF. THE 80% STENOSED TARGET LESION WAS LOCATED IN A FISTULA VENOUS ANASTOMOSIS OF THE LEFT ARM. A SUPER INTRODUCER SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RADIOPLAQUE TIP BROKE OFF WHEN PULLING THE SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT WAS NOT INTACT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 12434277 ↗MalfunctionMay 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10038548 ↗MalfunctionMay 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10038514 ↗MalfunctionMay 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10038513 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10036750 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10036677 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10035773 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10035722 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10035693 ↗
Other Togo Medikit CO.,Ltd. products
All Togo Medikit CO.,Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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